We live in an age where the use of computers and software systems are directly integrated into the practice and delivery of healthcare. This digitization of healthcare has led to innovations such as electronic health records, telemedicine, wearable devices, and even digital therapeutics. Many of these innovations generate, consume, or exchange vast amounts of data with other systems, providers, or even patients. Health data are now often being generated outside the clinical environment (via apps, wearable devices, and medications with sensors) and reported back to providers.
Patients are now routinely using new technologies to help manage and monitor their health. According to the FDA’s Digital Health Innovation Action Plan, “Digital health technologies can empower consumers to make better-informed decisions about their own health and provide new options for facilitating prevention, early diagnosis of life-threatening diseases, and management of chronic conditions outside of traditional care settings.” However, technological advantages also present unique challenges. As some experts have pointed out, “many fundamental problems remain unchanged—and not all challenges of digital medicine can be resolved by new technologies alone.”
With this ever-growing use of technology, as well as ever-increasing volume of health data (including genetic information, medications, labs, vital signs, and social determinants of health), how do we ensure that the digital realm is effectively structured to optimize care, therapies, access, and outcomes? This is where your contribution is essential.
A vast ecosystem of health data that can impact outcomes
Today’s healthcare system comprises a vast data ecosystem. In order to have positive impact on outcomes, the information within this ecosystem needs to be high-quality, up-to-date, and interoperable.
Even with increasing federal support of the expanded use of technology within healthcare (going back to the ARRA HITECH Act of 2009), a provider’s ability to harness the power of this electronic transformation is not yet uniformly available or optimized. In fact, the effect of missing data, poor-quality data, or data that’s not interoperable (i.e., can’t be exchanged seamlessly among various systems), can lead to negative or potentially fatal patient outcomes.
Drug Allergies and Intolerances
For example, there is no objective, scientifically vetted standard to provide an interoperable means to capture and exchange a patient’s drug allergies and intolerances. Drug allergies are often documented at the class level (e.g. “statin allergy”, or “beta-lactams allergy”), as opposed to the specific ingredient that caused the allergy or adverse event. This could leave the provider unclear as to which specific medication caused the adverse event, as well as which medications may be an acceptable alternative to prescribe while avoiding the adverse event caused by the original drug. This can potentially lead to patients having preventable allergic reactions or unnecessary escalation of medication.
At USP, we’re working to improve encoding and documentation around allergies and cross-sensitivities along the medication spectrum. As this is a broad landscape, USP is starting with addressing the classes of drugs that cause the most frequent and most severe drug allergies or intolerances: NSAIDs, cardiovascular drugs (ACE inhibitors, ARBs, statins), opioids, and antibiotics.
This work, which began in 2015 under the Healthcare Quality and Safety Committee, will integrate with the newly formed Health Information & Technology (HI&T) Expert Committee. Expert Committee volunteers will help create drug allergy value sets—groupings of content related to drugs and their potential adverse characteristics—that can be loaded into clinical decision support systems. These data sets aim to improve the quality, interoperability, and understanding of drug allergy and adverse event documentation within Health IT systems, allowing providers to make more informed, safer prescribing decisions for patients.
Electronically capturing information for compounded drugs presents similar challenges within Health IT systems. These drugs are tailored to meet the individual needs of a patient who cannot be treated with commercially available medication. Orders for prepared compounded oral medications are typically created on paper, by phone call or fax—vastly inhibiting their interoperability and cross-setting capacities. Today’s systems lack standardization to capture and exchange many commonly compounded drugs (such as nonsterile compounded oral liquids for pediatric patients), which leads to a breakdown in communication among providers and pharmacies, such as in transitions of care. Pediatric patients are particularly at risk when they require a compounded medication due to lack of interoperable standards in e-prescribing, dispensing, and other related systems. One study involving compounded drugs dispensed to pediatric patients founds that 4% of cases involved major, real or potential consequences
One of the goals of the HI&T Expert Committee is to develop an interoperable model to exchange compounded drug information so that these types of compounded preparations appear properly in patient orders and records. Once interoperability standards are in place, compounded medications can more easily be compared to other medications for drug allergies, interaction indications, and other warnings similar to those in finished drug products.
Pharmacogenomics (PGx) is an important example of a field of precision medicine where medical treatment is tailored to each person or a group of people. However, many clinicians are reluctant to utilize PGx data into their clinical practice. Informatics can play a key role in translating the science of patient-specific optimal medication therapy - based on the patient’s genetic profile - into the electronic health record environment. These data can then be integrated into Clinical Decision Support (CDS) and provide predictive models, such as recommending pre-emptive genotyping for patients exceeding particular risk thresholds.
How to contribute
Looking forward to the 2020-2025 cycle, The HI&T Expert Committee will seek to explore the creation of standards, models, and reference data that aim to mitigate the public health risk and patient safety issues caused by missing, non-standardized data or architecture. This content should leverage other vocabulary and messaging standards in use today, such as RxNorm, SNOMED CT, HL7 FHIR, NCPDP Script, ) etc.
Health IT is a challenging, exciting and rapidly transforming field. This is an opportunity for volunteers to lead and shift some of the most important work in healthcare today. The expert committee in this field will help discover potentially groundbreaking standardization mechanisms that can lead to greater public health outcomes, heightened patient safety, and practice efficiency.
The right volunteers can help us produce standards that will have a nationwide and global effect that may revolutionize public health. Together, we can move the needle in a number of critical areas and make a difference to every patient and community at large. We encourage experts with clinical experience—doctors, nurses, pharmacists, clinical informaticists—and others experienced in patient care—to apply to our Open Call for Candidates.